Vejle, Denmark
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Ingeman M.L.,Research Unit for General Practice | Ingeman M.L.,Research Center for Cancer Diagnosis in Primary Care CaP | Ingeman M.L.,University of Aarhus | Ormstrup T.E.,Vejle Regional Hospital | And 2 more authors.
Family Practice | Year: 2015

Background. Abdominal ultrasound (US) is a safe and low-cost diagnostic tool for various abdominal symptoms. Direct-access to US from general practice has been suggested as a feasible option to promote earlier cancer diagnosis because abdominal cancer often presents with nonspecific and vague symptoms, and the exact location may be difficult to identify on the basis of symptoms alone. Objective. To describe patterns of use and cancer prevalence in referred patients when providing Danish GPs with direct-access to hospital-based US. Methods. In an observational study, GPs were given the opportunity to either refer patients directly to US or through a waiting-list at Vejle Regional Hospital in Denmark; 701 patients were included between 1 August 2009 and 31 January 2010. Data were retrieved from the local Radiology Information System, GP referrals and the Danish Cancer Registry. Results. GPs referred 60% of all patients to direct-access US. Cancer was diagnosed in 19 (2.7%) of the referred patients within 6 months after the US investigation. US gave rise to the suspicion of cancer in 11 of these patients (57.9%); 10 of these had been referred to direct-access US. At least one non-malignant diagnosis resulted from US in 59.5% of the cases, while 37.8% of the cases had no final diagnosis. Conclusion. The findings in this study might indicate that GPs refer patients assessed to have a higher risk of cancer through direct-access US. The finding was statistically non-significant, and further research is required to confirm this result. © The Author 2015.


PubMed | University of Aarhus, Vejle Regional Hospital and Research Unit for General Practice
Type: Journal Article | Journal: Family practice | Year: 2015

Abdominal ultrasound (US) is a safe and low-cost diagnostic tool for various abdominal symptoms. Direct-access to US from general practice has been suggested as a feasible option to promote earlier cancer diagnosis because abdominal cancer often presents with non-specific and vague symptoms, and the exact location may be difficult to identify on the basis of symptoms alone.To describe patterns of use and cancer prevalence in referred patients when providing Danish GPs with direct-access to hospital-based US.In an observational study, GPs were given the opportunity to either refer patients directly to US or through a waiting-list at Vejle Regional Hospital in Denmark; 701 patients were included between 1 August 2009 and 31 January 2010. Data were retrieved from the local Radiology Information System, GP referrals and the Danish Cancer Registry.GPs referred 60% of all patients to direct-access US. Cancer was diagnosed in 19 (2.7%) of the referred patients within 6 months after the US investigation. US gave rise to the suspicion of cancer in 11 of these patients (57.9%); 10 of these had been referred to direct-access US. At least one non-malignant diagnosis resulted from US in 59.5% of the cases, while 37.8% of the cases had no final diagnosis.The findings in this study might indicate that GPs refer patients assessed to have a higher risk of cancer through direct-access US. The finding was statistically non-significant, and further research is required to confirm this result.


Axelsen M.B.,Copenhagen University | Eshed I.,Tel Aviv University | Horslev-Petersen K.,King Christian 10th Hospital for Rheumatic Diseases | Horslev-Petersen K.,University of Southern Denmark | And 35 more authors.
Annals of the Rheumatic Diseases | Year: 2015

Objectives: To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect. Methods: In a double-blind, placebo-controlled trial, 85 disease-modifying antirheumatic drug-naïve patients with ERA were randomised to receive methotrexate, intraarticular glucocorticosteroid injections and placebo/adalimumab (43/42). Contrast-enhanced MRI of the right hand was performed at months 0, 6 and 12. Synovitis, osteitis, tenosynovitis, MRI bone erosion and joint space narrowing (JSN) were scored with validated methods. Dynamic contrast-enhanced MRI (DCE-MRI) was carried out in 14 patients. Results: Synovitis, osteitis and tenosynovitis scores decreased highly significantly (p<0.0001) during the 12-months' follow-up, with mean change scores of-3.7 (median-3.0), -2.2 (-1) and -5.3 (-4.0), respectively. No overall change in MRI bone erosion and JSN scores was seen, with change scores of 0.1 (0) and 0.2 (0). The tenosynovitis score at month 6 was significantly lower in the adalimumab group, 1.3 (0), than in the placebo group, 3.9 (2), Mann-Whitney: p<0.035. Furthermore, the osteitis score decreased significantly during the 12-months' follow-up in the adalimumab group, but not in the placebo group, Wilcoxon: p=0.001-0.002 and p=0.062-0.146. DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters. Clinical measures decreased highly significantly during follow-up. Conclusions: A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis, osteitis and tenosynovitis and halted structural damage progression as judged by MRI. The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis.


Axelsen M.B.,Copenhagen University | Eshed I.,Tel Aviv University | Horslev-Petersen K.,King Christian 10th Hospital for Rheumatic Diseases | Horslev-Petersen K.,University of Southern Denmark | And 35 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect. Methods: In a double-blind, placebo-controlled trial, 85 disease-modifying antirheumatic drug-naïve patients with ERA were randomised to receive methotrexate, intra-articular glucocorticosteroid injections and placebo/adalimumab (43/42). Contrast-enhanced MRI of the right hand was performed at months 0, 6 and 12. Synovitis, osteitis, tenosynovitis, MRI bone erosion and joint space narrowing (JSN) were scored with validated methods. Dynamic contrast-enhanced MRI (DCE-MRI) was carried out in 14 patients. Results: Synovitis, osteitis and tenosynovitis scores decreased highly significantly (p<0.0001) during the 12-months' follow-up, with mean change scores of -3.7 (median -3.0), -2.2 (-1) and -5.3 (-4.0), respectively. No overall change in MRI bone erosion and JSN scores was seen, with change scores of 0.1 (0) and 0.2 (0). The tenosynovitis score at month 6 was significantly lower in the adalimumab group, 1.3 (0), than in the placebo group, 3.9 (2), Mann-Whitney: p<0.035. Furthermore, the osteitis score decreased significantly during the 12-months' follow-up in the adalimumab group, but not in the placebo group, Wilcoxon: p=0.001-0.002 and p=0.062-0.146. DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters. Clinical measures decreased highly significantly during follow-up. Conclusions: A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis, osteitis and tenosynovitis and halted structural damage progression as judged by MRI. The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis. © 2014 BMJ Publishing Group Ltd & European League Against Rheumatism.


Horslev-Petersen K.,King Christian 10th Hospital for Rheumatic Diseases | Horslev-Petersen K.,University of Southern Denmark | Hetland M.L.,Glostrup Hospital | Hetland M.L.,Copenhagen University | And 20 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: An investigator-initiated, double-blinded, placebo-controlled, treat-to-target protocol (Clinical Trials: NCT00660647) studied whether adalimumab added to methotrexate and intra-articular triamcinolone as first-line treatment in early rheumatoid arthritis (ERA) increased the frequency of low disease activity (DAS28CRP<3.2) at 12 months. Methods In 14 Danish hospital-based clinics, 180 disease-modifying anti-rheumatic drugs (DMARD)-naïve ERA patients (<6 months duration) received methotrexate 7.5 mg/week (increased to 20 mg/week within 2 months) plus adalimumab 40 mg every other week (adalimumab-group, n=89) or methotrexate +placebo-adalimumab (placebo-group, n=91). At all visits, triamcinolone was injected into swollen joints (max. four joints/visit). If low disease activity was not achieved, sulfasalazine 2 g/day and hydroxychloroquine 200 mg/day were added after 3 months, and open-label biologics after 6-9 months. Efficacy was assessed primarily on the proportion of patients who reached treatment target (DAS28CRP<3.2). Secondary endpoints included DAS28CRP, remission, Health Assessment Questionnaire (HAQ), EQ-5D and SF-12. Analysis was by intention-to-treat with last observation carried forward. Results Baseline characteristics were similar between groups. In the adalimumab group/placebo group the 12-month cumulative triamcinolone doses were 5.4/7.0 ml (p=0.08). Triple therapy was applied in 18/27 patients (p=0.17). At 12 months, DAS28CRP<3.2 was reached in 80%/76% (p=0.65) and DAS28CRP was 2.0 (1.7-5.2) (medians (5th/95th percentile ranges)), versus 2.6 (1.7-4.7) (p=0.009). Remission rates were: DAS28CRP<2.6:74%/49%, Clinical Disease Activity Index≤2.8:61%/41%, Simplified Disease Activity Index<3.3:57%/37%, European League Against Rheumatism/American College of Rheumatology Boolean: 48%/30% (0.0008


Munkedal D.L.E.,Aarhus University Hospital | Laurberg So.,Aarhus University Hospital | Hagemann-Madsen R.,Vejle Regional Hospital | Stribolt K.J.,Aarhus University Hospital | And 3 more authors.
Diseases of the Colon and Rectum | Year: 2016

BACKGROUND: After the introduction of complete mesocolic excision, a new pathological evaluation of the resected colon cancer specimen was introduced. This concept has quickly gained acceptance and is often used to compare surgical quality. The grading of colon cancer specimens is likely to depend on both surgical quality and the training of the pathologist. OBJECTIVE: The purpose of this study was to validate the principles of the pathological evaluation of colon cancer specimens. DESIGN: This was an exploratory study. SETTINGS: The study was conducted in Aarhus, Denmark, and Leeds, United Kingdom. PATIENTS: Colon cancers specimens were used. MAIN OUTCOME MEASURES: The agreement of gradings between participants was of interest. Four specialist GI pathologists and 2 abdominal surgeons evaluated 2 rounds of colon cancer specimens, each at 2 separate time points. Each round contained 50 specimens. After the first round, a protocol of detailed principles for the grading procedure was agreed on. Results from an experienced pathologist were considered as the reference results. RESULTS: In the first round, the distribution of gradings between participants showed substantial variation. In the second round, the variation was reduced. Intraobserver agreement was mostly fair to good, whereas interobserver agreement was frequently poor. This did not significantly change from round 1 to round 2. LIMITATIONS: The small sample size of 100 specimens provided a very small number of specimens resected in the muscularis propria plane, which renders the evaluation of this group potentially unreliable. The evaluations were made on photos and not on fresh specimens. CONCLUSIONS: This study demonstrates significant variation in the pathological evaluation of colon cancer specimens. It demonstrates that it cannot be used in clinical studies, and care should be taken when comparing results between different hospitals. © The ASCRS 2016.


Horslev-Petersen K.,University of Southern Denmark | Hetland M.L.,Copenhagen University | Hetland M.L.,Glostrup Hospital | Ornbjerg L.M.,Copenhagen University | And 20 more authors.
Annals of the Rheumatic Diseases | Year: 2016

Objectives: To study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647). Methods: Disease-modifying antirheumatic drug (DMARD)-naive patients with eRA started methotrexate (20 mg/week) and intra-articular triamcinolone (20 mg/ ml) for 2 years. In addition, they were randomised to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40 mg/every other week) (DMARD +adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine were added if disease activity persisted after 3 months. During year 2, synthetic DMARDs continued. Adalimumab was (re) initiated if active disease reoccurred. Clinical response, remission, disability, quality of life and radiographic changes were assessed. Results: One year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups. In the DMARD/DMARD+adalimumab groups, the median 2-year methotrexate dose was 20/20 mg/week ( p=0.45), triple DMARD therapy had been initiated in 33/27 patients ( p=0.49), adalimumab was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120 mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) ≤3.2 or DAS28<3.2 without swollen joints) was achieved at all visits in ≥85% of patients in year 2; remission rates were DAS28CRP<2.6:69%/66%; Clinical Disease Activity Index ≤2.8:55%/57%; Simplified Disease Activity Index <3.3:54%/49%; American College of Rheumatology/ European League against Rheumatism (28 joints):44%/ 45% (p=0.66-1.00). Radiographic progression (δtotal Sharp score/year) was similar 1.31/0.53 ( p=0.12). Erosive progression (δerosion score (ES)/year) was year 1:0.57/0.06 ( p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (δES≤0) was year 1: 59%/76% (p=0.03); year 2:64%/ 79% ( p=0.04). Conclusions: An aggressive triamcinolone and synthetic DMARD treat-to-target strategy in eRA provided excellent 2-year clinical and radiographic disease control independent of adalimumab induction therapy. ES progression was slightly less during and following adalimumab induction therapy. © 2016 Published by the BMJ Publishing Group Limited.


PubMed | Copenhagen University, Vejle Regional Hospital, Aarhus University Hospital, University of Southern Denmark and 4 more.
Type: Journal Article | Journal: Annals of the rheumatic diseases | Year: 2016

To study clinical and radiographic outcomes after withdrawing 1 years adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647).Disease-modifying antirheumatic drug (DMARD)-naive patients with eRA started methotrexate (20mg/week) and intra-articular triamcinolone (20mg/ml) for 2 years. In addition, they were randomised to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40mg/every other week) (DMARD+adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine were added if disease activity persisted after 3 months. During year 2, synthetic DMARDs continued. Adalimumab was (re)initiated if active disease reoccurred. Clinical response, remission, disability, quality of life and radiographic changes were assessed.One year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups. In the DMARD/DMARD+adalimumab groups, the median 2-year methotrexate dose was 20/20mg/week (p=0.45), triple DMARD therapy had been initiated in 33/27 patients (p=0.49), adalimumab was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) 3.2 or DAS28>3.2 without swollen joints) was achieved at all visits in 85% of patients in year 2; remission rates were DAS28CRP<2.6:69%/66%; Clinical Disease Activity Index 2.8:55%/57%; Simplified Disease Activity Index <3.3:54%/49%; American College of Rheumatology/European League against Rheumatism (28 joints):44%/45% (p=0.66-1.00). Radiographic progression (total Sharp score/year) was similar 1.31/0.53 (p=0.12). Erosive progression (erosion score (ES)/year) was year 1:0.57/0.06 (p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (ES0) was year 1: 59%/76% (p=0.03); year 2:64%/79% (p=0.04).An aggressive triamcinolone and synthetic DMARD treat-to-target strategy in eRA provided excellent 2-year clinical and radiographic disease control independent of adalimumab induction therapy. ES progression was slightly less during and following adalimumab induction therapy.NCT00660647.

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